Stomal device including means to prolong attachment of flange

ABSTRACT

Cover disc located in the area between a flange and the stoma is employed to periodically deliver a hydrocolloid containing ointment or non-aqueous paste to seal off the area around the stoma. Seepage of fluid passing from the stoma to a bag attached to the flange is absorbed by the ointment and prevented from weakening the adhesive bond attaching the flange to the skin.

United States Patent Chen .1 ames Ling 1 Sept. 23, 1975 STOMAL DEVICE INCLUDING MEANS TO PROLONG ATTACHMENT OF FLANGE Inventor: Chen James Ling, East Brunswick,

E. R. Squibb & Sons, Inc., Princeton, NJ.

Filed: Aug. 5, 1974 Appl. No.: 494,781

Assignee:

US. Cl. 128/283; 128/260 Int. Cl. A61F 5/44 Field of Search 128/1 R, 154-157, 128/163, l7l172, 260-261, 268, 272, 275, 283, 350 R, 2 F, 294-295 References Cited UNITED STATES PATENTS 2/1963 Berger 128/283 3.373.745 3/1968 Benfield et al 128/283 3,520,301 7/1970 Fenton 128/283 3.713.445 l/1973 Marsan 128/283 3.805.789 4/1974 Marsan [28/283 Primary E.\'aminerRiChard A. Gaudet Assistant Examiner-Rick Opitz Attorney, Agent, or FirmLawrencc S. Levinson; Merle .1. Smith; Stephen B. Davis [57] ABSTRACT Cover disc located in the area between a flange and the stoma is employed to periodically deliver a hydrocolloid containing ointment or non-aqueous paste to seal off the area around the stoma. Seepage of fluid passing from the stoma to a bag attached to the flange is absorbed by the ointment and prevented from weakening the adhesive bond attaching the flange to the skin.

13 Claims, 3 Drawing Figures .1 STOMAL DEVICE INCLUDING MEANS TO PROLONG ATTACI-IIVENT OF FLANGE BACKGROUND OF THE INVENTION Stomal devices comprising a flange which is affixed to the skin and a disposable stoma bag attached to the flange by means of an elastic band are known. The flange is affixed to the skin by means of a double-sided pressure adhesive disc which is adhered either directly to the skin or to a peristomal covering which is adhered to the skin. The period of time for which the flange remains affixed to the skin is limited due to the fact that seepage occurs in the area of the stoma which weakens the adhesive bond.

SUMMARY OF THE INVENTION This invention relates to an improvement over the stomal device described above. It relates to means whereby the seepage of fluid from the area of the stoma is retarded thus permitting the flange to remain affixed to the skin for a longer period of time. This result is achieved by the use of a disc located within the periphery of the flange which is manipulated to release amounts of a fluid absorbing ointment or non-aqueous paste in the area around the stoma.

FIG. 1 is a top view of the stoma] device without the attached bag.

FIG. 2 is a side view along the line 2-2 of FIG. 1 without the attached bag.

FIG. 3 is the same as FIG. 2 except the peristomal covering is omitted and the attached bag is shown.

DETAILED DESCRIPTION Referring now to the drawings in more particular detail, the stomal device comprises flange 11 to which stoma bag 12 is attached by suitable means such as an elastic band 13 (see FIG. 3). The flange 11 is bound to one side of a double-sided pressure sensitive adhesive member 14. The adhesive member 14 can be formed in the shape of a disc comprising polymer film or closed-cell plastic foam having a pressure sensitive adhesive coating on both sides. The adhesive disc 14 has a centrally located hole adapted to fit around the stoma 18. The other side of the pressure sensitive adhesive disc 14 can be pressed firmly against the skin as shown in FIG. 3. Alternatively, the other side of adhesive disc 14 can be affixed to a peristomal covering 15, as shown in FIG. 2, which can be pressed firmly against the skin 10. The peristomal covering 15 also has a centrally located hole adapted to fit around the stoma 18.

The peristomal covering 15 consists of an adhesive bonding composition comprising a pressure-sensitive rubbery elastomer adhesive component having intimately dispersed therein a Water soluble or swellable hydrocolloid and a thin pliable water insoluble film secured to one side. Such coverings or bandages are described in U.S. Pat. No. 3,339,546 whose disclosure is incorporated herein by reference. The adhesive disc 14, of course, is attached to the film side of covering 15, see FIG. 2. The covering 15 can be of any shape although rectangular as shown in FIG. 1 is preferred. It is also possible to form the adhesive member 14 directly from the adhesive bonding composition described above by omitting the thin water insoluble film.

The flange 1 1 is formed from relatively rigid material such as various polymeric materials including polyethylene, polycarbonate, polyvinyl chloride, linear polyethylene, polystyrene, etc., or metals such as aluminum and stainless steel. Flange 11 includes side wall 19, bottom wall 20, and upper lip 21, as seen in FIGS. 2 and 3. The flange can be of any shape such as rectangular or oval although circular as shown in FIG. 1 is preferred. The side wall 19 is generally straight as shown in FIGS. 2 and 3 although it can also be formed with a slight slope. The bottom wall 20 is generally perpendicular to side wall 19, see FIGS. 2 and 3, and extends outwardly therefrom. Bottom wall 20 can also be constructed so that it extends inwardly from side wall 19 provided that a sufficiently large opening remains for passage of stoma 18. The bottom wall 20 attached to the adhesive member 14. Upper lip 21 functions to prevent accidental detachment of stoma bag 12 due to slippage of elastic band 13.

The disposable stoma bag 12 is formed from any suitable flexible polymeric film such as polyethylene or polypropylene.

This invention is the inclusion of cover disc 17 which releases an amount of ointment or non-aqueous paste 16 in the area of the stoma 18. As can best be seen in FIGS. 2 and 3, the ointment or paste 16 is located in the space between cover disc 17, flange side wall 19, and adhesive member 14.

The ointment or non-aqueous paste 16 is formed of a mixture of an oil component such as mineral oil or vegetable oil and a water soluble or swellable hydrocolloid or mixtures thereof, such as polyvinylalcohol, powdered pectin, gelatin, sodium carboxymethylcellulose, high molecular weight carbowax, carboxypolymethylene and other like substances. The hydrocolloid is present at a level of from about 25 to about by weight, with about 30 to about 55% by weight being preferred. Medicaments such as antiinflammatory agents and deodorants can also be included within the ointment or nonaqueous paste 16.

The cover disc 17 is rigid or semi-rigid and about 1 to about 3 mm. thick. The rigidity is such that the cover disc 17 will not bend or deform when pressed by hand. The cover disc 17 is formed from materials which are oil resistant and compatible with the ingredients in ointment l6. Polypropylene, polystyrene, polycarbonate, aluminum, and stainless steel are examples of materials suitable for this purpose. The cover disc 17 is shaped according to the shape of flange 11. Its dimensions are such that it will fit snugly within the flange side wall 19 and around stoma 18. Enough space should remain between cover disc 17 and stoma 18 so as to avoid rubbing of the inner edge of the cover disc on the stoma. Upon pressing cover disc 17 towards adhesive member 14 a quantity of ointment 16 will be forced upwards along the sides of stoma l8 and fill the space between cover disc 17 and stoma 18.

After the flange 11 has been attached to adhesive member 14 which in turn can optionally be attached to peristomal covering 15, a quantity of hydrocolloid containing ointment or paste 16 is loaded into the area between flange wall 19 and adhesive member 14. The properly sized cover disc 17 is inserted and the entire device is affixed to the skin. The covering disc 17 is pressed slightly to squeeze the hydrocolloid ointment 16 so as to seal off the space around the stoma 18. The disposable flexible stoma bag 12 is then attached to the flange by means of elastic band 13. After a period of time, the ointment or non-aqueous paste 16 will be come a soft hydrated mucilaginous paste due to the absorption of aqueous fluid from the excreta or urine which passed through the opening in stoma 18. The covering disc 17 is then pressed down with the fingers through the wall of the flexible stoma bag 12 without removing the bag or by pressing directly after the bag has been removed causing an amount of fresh ointment or paste 16 to reseal the space around the stoma 18. Thus, the aqueous fluid is continuously blocked and prevented from seeping to the adhesive member 14 or peristomal covering 15 and weakening the adhesive bonds which keep the device in place.

What is claimed is:

1. A stomal device comprising an adhesive member, a rigid flange means including a continuous side wall, outwardly extending bottom wall perpendicular to said side wall and an upper lip, said flange means affixed to one side of said adhesive member by an adhesive bond between said bottom wall and said adhesive member, both said adhesive member and said bottom wall having a centrally located opening to permit the device to encircle a stoma, a quantity of hydrocolloid containing ointment or non-aqueous paste located interior of said flange side wall and supported by said adhesive memher, a rigid or semi-rigid covering disc having a centrally located opening sized and shaped so as to snugly fit in the space between said flange side wall and said stoma with said covering disk opening in line with said adhesive member opening, whereby movement of said covering disc toward said adhesive member will force a portion of the hydrocolloid containing ointment or paste to fill the space between the stoma and said covering disc.

2. The stomal device of claim 1 including a flexible stoma bag attached to said flange by means of an elastic band whereby said flange upper lip prevents accidental detachment of said bag.

3. The stomal device of claim 1 wherein said ointment or non-aqueous paste comprises an oil component selected from mineral oil or vegetable oil and from about to about 75% by weight of a water soluble hydrocolloid, a water swellable hydrocolloid, or mixtures of water soluble and water swellable hydrocolloids.

4. The stomal device of claim 3 wherein said ointment or non-aqueous paste comprises from about 30 to about 55% by weight of hydrocolloid.

5. The stomal device of claim 3 wherein said cover disc is from about 1 to about 3 mm. thick and from materials which are resistant and compatible with the ingredients in the ointment or non-aqueous paste.

6. The stomal device of claim 1 wherein said adhesive member is a bonding composition comprising a pressure sensitive rubbery elastomer adhesive having intimately dispersed therein a water soluble or water swellable hydrocolloid.

7. The stomal device of claim 1 wherein said adhesive member is an adhesive disc comprising a polymer film or closed-cell plastic foam having a pressure sensitive adhesive coating on both sides.

8. The stomal device of claim 7 wherein the other side of said adhesive disc is attached to a peristomal covering comprising a bonding composition having a thin water insoluble backing film, said adhesive disc attached to said film.

9. The stomal device of claim 8 wherein said adhesive disc and said cover disc are circular and said peristomal covering is rectangular.

10. The stomal device of claim 8 including a flexible stoma bag attached to said flange by means of an elastic band whereby said flange upper lip prevents accidental detachment of said bag.

11. The stomal device of claim 10 wherein said ointment or non-aqueous paste comprises an oil component selected from mineral oil or vegetable oil and from about 25 to about by weight of a water soluble hydrocolloid, a water swellable hydrocolloid, or a mixture of water soluble and water swellable hydrocolloids.

12. The stomal device of claim 11 wherein said ointment or non-aqueous paste comprises from about 30 to about 55% by weight of hydrocolloid.

13. The stomal device of claim 12 wherein said cover disc is from about 1 to about 3 mm. thick and from materials which are resistant and compatible with the ingredients in the ointment or non-aqueous paste.

UNITED STATES PATENT AND TRADEMARK OFFICE CERTIFICATE 0E CORRECTION PATENT NO. 3,906,951

DATED Sept. 23 1975 |NV.ENTOR(S) James L. Chen It is certified that error appears in the ab0ve-identified patent and that said Letters Patent are hereby corrected as shown below:

The inventor's name should read -James Ling Chen--.

Col. 2, line 13, "attached" should read -attaches-.

Col. 3, line 27, "disk" should read -disc-.

Signed and Sealed this Third Day of August 1976 [SEAL] Arrest:

RUTH C. MASON C. MARSHALL DANN Arresting Officer Commissioner ufParents and Trademarks 

1. A STOMAL DEVICE COMPRISING AN ADHESIVE MEMBER, A RIGID FLANGE MEANS INCLUDING A CONTINUOUS SIDE WALL, OUTWARDLY EXTEDING BOTTOM WALL PERPENDICULAR TO SAID SIDE WALL AND AN UPPER LIP, SAID FLANGE MEANS AFFIXED TO ONE SIDE OF SAID ADHESIVE MEMBER BY AN ADHESIVE BOND BETWEEN SAID BOTTOM WALL AND SAID ADHESIVE MEMBER, BATH SAID ASHESIVE MEMBER AND SAID BOTTOM WALL HAVING A CENTRALLY LOCATED OPENING TO PERMIT THE DEVICE TO ENCIRCLE A STOMA, A QUANTITY OF HYDROCOLLOID CONTAINING OINTMENT OR NON-AQUEOUSPASTE LOCATED INTERIOR OF SAID FLANGE SIDE WALL AND SUPPORTED BY SAID ADHESIVE MEMBER, A RIGID OR SEMI-RIGID COVERING DISC HAVING A CENTRALLY LOCATED OPENING SIZED AND SHAPED SO AS TO SNUGLY FIT IN THE SPACE BE-
 2. The stomal device of claim 1 including a flexible stoma bag attached to said flange by means of an elastic band whereby said flange upper lip prevents accidental detachment of said bag.
 3. The stomal device of claim 1 wherein said ointment or non-aqueous paste comprises an oil component selected from mineral oil or vegetable oil and from about 25 to about 75% by weight of a water soluble hydrocolloid, a water swellable hydrocolloid, or mixtures of water soluble and water swellable hydrocolloids.
 4. The stomal device of claim 3 wherein said ointment or non-aqueous paste comprises from about 30 to about 55% by weight of hydrocolloid.
 5. The stomal device of claim 3 wherein said cover disc is from about 1 to about 3 mm. thick and from materials which are resistant and compatible with the ingredients in the ointment or non-aqueous paste.
 6. The stomal device of claim 1 wherein said adhesive member is a bonding composition comprising a pressure sensitive rubbery elastomer adhesive having intimately dispersed therein a water soluble or water swellable hydrocolloid.
 7. The stomal device of claim 1 wherein said adhesive member is an adhesive disc comprising a polymer film or closed-cell plastic foam having a pressure sensitive adhesive coating on both sides.
 8. The stomal device of claim 7 wherein the other side of said adhesive disc is attached to a peristomal covering comprising a bonding composition having a thin water insoluble backing film, said adhesive disc attached to said film.
 9. The stomal device of claim 8 wherein said adhesive disc and said cover disc are circular and said peristomal covering is rectangular.
 10. The stomal device of claim 8 including a flexible stoma bag attached to said flange by means of an elastic band whereby said flange upper lip prevents accidental detachment of said bag.
 11. The stomal device of claim 10 wherein said ointment or non-aqueous paste comprises an oil component selected from mineral oil or vegetable oil and from about 25 to about 75% by weight of a water soluble hydrocolloid, a water swellable hydrocolloid, or a mixture of water soluble and water swellable hydrocolloids.
 12. The stomal device of claim 11 wherein said ointment or non-aqueous paste comprises from about 30 to about 55% by weight of hydrocolloid.
 13. The stomal device of claim 12 wherein said cover disc is from about 1 to about 3 mm. thick and from materials which are resistant and compatible with the ingredients in the ointment or non-aqueous paste. 